One goal of a technology-based health care system that fully integrates the technical and social aspects of patient care and therapy is to connect the client with care providers irrespective of separation distance or location of the participants. While clinicians will continue to treat patients in accordance with accepted medical practice, developments in communications technology are making it ever more possible to provide medical services in a time- and place-independent manner.
Past methods of clinical services are generally limited to in-hospital operations. For example, if a physician needs to review the performance parameters of an implantable device in a patient, the patient normally has to go to the clinic. Further, if the medical conditions of a patient with an implantable device warrant continuous monitoring or adjustment of the device, the patient would have to stay in a hospital indefinitely. Such a continued treatment plan poses both economic and social problems. Under the exemplary scenario, as the segment of the population with implanted medical devices increases many more hospitals/clinics and service personnel will be needed to provide in-hospital service for the patients, thus escalating the cost of healthcare. Additionally the patients will be unduly restricted and inconvenienced by the need to either stay in the hospital or make very frequent visits to a clinic.
Yet another condition of the past practice requires that a patient visit a clinical center for occasional retrieval of data from the implanted device to assess the operations of the device and gather patient history for both clinical and research purposes. Such data is acquired by having the patient in a hospital/clinic to download the stored data from the implantable medical device. Depending on the frequency of data collection, this procedure may pose a serious difficulty and inconvenience for patients who live in rural areas or have limited mobility. Similarly, in the event a need arises to upgrade the software of an implantable medical device, the patient will be required to come into the clinic or hospital to have the upgrade installed.
A further limitation of past practice relates to the management of multiple implantable devices in a single patient. Advances in patient therapy and treatment have made it possible to implant a number of devices in a patient. For example, implantable devices such as a defibrillator and/or a pacer, a neural implant, a drug pump, a separate physiologic monitor and various other implantable devices may be implanted in a single patient. To successfully manage the operations and assess the performance of each device in a patient with multiple implants requires a regular update and monitoring of the devices. Further, it may be preferred to have an operable communication between the various implants to provide a coordinated clinical therapy to the patient. Thus, there is a need to monitor the performance of the implantable devices on a regular, if not a continuous, basis to ensure optimal patient care. In the absence of other alternatives, this imposes a great burden on the patient if a hospital or clinic is the only center where the necessary frequent follow up, evaluation and adjustment of the medical devices could be made. Moreover, even if feasible, the situation would require the establishment of multiple service areas or clinic centers to provide adequate service to the burgeoning number of multi-implant patients worldwide. Accordingly, a programmer unit that would connect to a remote expert medical center to provide access to expert systems and import the expertise to a local environment is desirable. This approach would enable unencumbered access to the IMD or the patient.
To address these needs, a number of proposals have been made to enable remote programming and monitoring of an IMD from a centralized center. Using modern communications technologies, data may be transferred from a centralized programming instrument to a remote programming instrument located in the vicinity of a patient for transferring instructions received from the central location to the IMD. In U.S. Pat. No. 6,497,655 (Linberg et al.), a system is generally disclosed in which software programs are implemented in a web-enabled high-speed computer system to remotely monitor, manage and modify operation and functional parameters of a plurality of IMDs. In U.S. Pat. No. 6,442,433 (Linberg), a system for remote troubleshooting, maintenance and upgrade of implantable device systems is generally disclosed wherein a programmer operating in association with a diverse number of implantable medical devices is in bi-directional operable data, voice, and video communications with a remote web-based expert data center. In U.S. Pat. No. 6,363,282 (Nichols), a system and method for providing an automated software update to a programmer or equivalent device used in implantable medical device systems is generally disclosed. A system and method for providing automated self-identification information of a remote medical component of an implantable medical device system to a centralized computer is generally disclosed in U.S. patent application Pub. No. 2002/0040234 (Linberg). A system for transferring data into and out of medical devices wherein a personal data manager is used in a web-based network is generally disclosed in U.S. Pat. No. 6,418,346 (Nelson, et al.) A passive communication scheme between one or more external instruments communicable with one or more IMDs and with a remote central server or a network where data is stored is generally disclosed in U.S. Pat. No. 6,574,511 (Lee). A system and method for remote invoicing an inventory control of medical components of an implantable medical device system upon implantation in a patient is described in U.S. Pat. No. 6,385,593 (Linberg). All of the above patents are hereby incorporated herein by reference in their entirety.
The systems provide advantages with regard to remote patient management, but potential risks remain. Potential risks associated with remote IMD programming capabilities include inappropriate programming of an IMD or an adverse response to programming changes occurring when a patient is not under medical supervision. Furthermore, secure transfer of medical information across communication systems is important in protecting patient privacy.